Davis M J, Dawes P T, Fowler P D, Clarke S, Fisher J, Shadforth M F
Staffordshire Rheumatology Centre, Stoke-on-Trent.
Br J Rheumatol. 1991 Dec;30(6):451-4. doi: 10.1093/rheumatology/30.6.451.
A 12-month double-blind controlled study comparing hydroxychloroquine 400 mg daily with placebo in 104 patients with mild RA was conducted to see whether patients with mild rheumatoid arthritis (RA) benefit from treatment with disease-modifying agents. Mild RA was defined as synovitis limited to the hands and feet, an ESR less than 30 mm/h and C-reactive protein less than 20 mg/l, a situation where accepted clinical practice is to use a non-steroidal anti-inflammatory agent alone. By 6 months, the improvement of clinical and laboratory parameters in the hydroxychloroquine treated patients was significant compared with pretreatment levels and significantly greater than the control group. This improvement was maintained at 12 months. In addition, fewer patients withdrew through lack of efficacy, eight on hydroxychloroquine versus 18 on placebo. The implications of treating this well defined group of patients is discussed.
开展了一项为期12个月的双盲对照研究，将104例轻度类风湿性关节炎（RA）患者每日服用400毫克羟氯喹与服用安慰剂进行比较，以观察轻度类风湿性关节炎患者是否能从病情缓解药物治疗中获益。轻度RA被定义为滑膜炎局限于手足、红细胞沉降率（ESR）低于30毫米/小时且C反应蛋白低于20毫克/升，这种情况下公认的临床实践是单独使用非甾体抗炎药。到6个月时，与治疗前水平相比，羟氯喹治疗患者的临床和实验室参数改善显著，且明显优于对照组。这种改善在12个月时得以维持。此外，因缺乏疗效而退出研究的患者较少，服用羟氯喹的有8例，服用安慰剂的有18例。文中讨论了治疗这一明确界定患者群体的意义。
